Shanxi GSP follow-up inspection, 65 enterprises were named

Recently, Shanxi Provincial Food and Drug Administration issued the notice of GSP follow-up and inspection plan for pharmaceutical trading enterprises (hereinafter referred to as "the notice"), which requires the municipal market supervision administration and the provincial audit and inspection center to carefully organize and implement in accordance with the plan of GSP follow-up and inspection for pharmaceutical trading enterprises in 2019 The details are as follows: in 2019, the GSP follow-up inspection plan for pharmaceutical trading enterprises is to urge the pharmaceutical trading enterprises to continue to comply, continuously improve the level of pharmaceutical quality management, and strictly prevent the quality and safety risks of pharmaceutical trading According to the provisions of the measures for the administration of quality management standard certification for pharmaceutical trading, and in line with the actual situation of our province, the GSP follow-up inspection plan for pharmaceutical trading enterprises in 2019 is formulated as follows: 1、 Inspection task: drug GSP tracking inspection objects in 2019: drug distributors that have passed the drug GSP certification in 2017-2018 and have not conducted tracking inspection since the renewal in 2014 Focus on the inspection of the operation of the quality management of the enterprise and the rectification of the problems found in the inspection, and urge the enterprise to continue to carry out drug trading activities in accordance with the drug GSP and relevant regulations When the flight inspection is consistent with the tracking inspection list, it can be organized and implemented together, and the inspection reports can be issued respectively 2、 Inspection Division (1) the provincial bureau is responsible for organizing the follow-up inspection of drug GSP in the whole province, determining the list of drug GSP follow-up inspection enterprises according to the requirements of the National Bureau and the provincial government, and publishing the results of follow-up inspection on the website of the Provincial Bureau （2） The audit and inspection center of the provincial bureau is responsible for the specific implementation of GSP follow-up inspection of the whole province's drug wholesale enterprises (including the drug retail chain headquarters), and the number of inspections is 60 （3） The municipal market supervision bureaus shall be responsible for organizing and implementing the follow-up inspection of drug retail enterprises within their respective jurisdictions The specific inspection list shall be determined by each municipal bureau according to the actual situation In principle, it is required to complete 100% coverage of drug dealers in the jurisdiction in 2014-2017 and 50% coverage of drug dealers in the jurisdiction in 2018 before the end of this year 3、 Work arrangement (I) inspection time: the provincial audit and inspection center shall report the relevant inspection report and non-conforming items organized and completed in the previous month to the drug circulation Supervision Office of the Provincial Bureau before the 5th day of each month The provincial audit and inspection center and the municipal market supervision bureaus shall complete the GSP tracking inspection task before October 31, 2019, and submit the written summary materials of the tracking inspection to the drug circulation Supervision Office of the Provincial Bureau before November 20 （2） Inspection methods GSP follow-up inspection shall be carried out in accordance with the "drug quality management specifications" and the "guidelines for on site inspection of drug quality management specifications (Revised)", and in combination with the requirements of the State Administration's Announcement No 94 in 2016, to comprehensively inspect the operation of the drug quality management system of enterprises, clarify the key contents and links of inspection, and truthfully record the defective items （3） Handling of inspection results According to the principle of supervision and inspection results in the guiding principles for on site inspection of drug distribution quality management specifications (Revised Version), the drug wholesale enterprises (retail chain headquarters) whose inspection results are determined as "violating the drug distribution quality management specifications and rectifying within a time limit" shall be jointly inspected by the drug circulation Supervision Office of the Provincial Bureau and the audit and inspection center of the Provincial Bureau The situation shall be checked and a rectification review report shall be issued; for the drug wholesale enterprises (retail chain headquarters) whose inspection results are determined as "seriously violating the drug trade quality management specifications and revoking the certificate of drug trade quality management specifications", the Provincial Bureau's audit and inspection center shall submit the inspection results to the Provincial Bureau within 5 working days after the completion of the inspection, and the Provincial Bureau shall revoke the inspection results according to law after the audit《 Certificate of quality management standard for drug distribution; if the inspection team finds any illegal or illegal operation of drug wholesale enterprises (retail chain headquarters) in the on-site inspection, it shall report to the Provincial Bureau in time and transfer it to the Provincial Bureau's inspection department for filing and investigation according to law If the municipal market supervision bureau finds that the drug retail enterprises have illegal or illegal business practices, it shall file a case for investigation and handle according to law, and report the relevant information to the Provincial Bureau 4、 Relevant requirements (I) strengthen organizational leadership, strictly implement responsibilities, carry out GSP certification follow-up inspection, and urge enterprises to operate in accordance with the law, continue to comply, and implement important means of main responsibility Market supervision departments at all levels shall strictly implement the responsibility of territorial supervision, organize and implement GSP follow-up inspection in a planned, step-by-step and targeted manner in combination with the local reality to ensure the quality of follow-up inspection （2） Overall planning and coordination, pay close attention to work implementation All units shall organically combine the drug GSP follow-up inspection with daily supervision and inspection, special inspection and flight inspection, coordinate all aspects of work, reasonably arrange the time, highlight the key points of inspection, ensure that the follow-up inspection task is completed on time and with high quality, analyze and judge the problems found in the follow-up inspection, and put forward reasonable suggestions （3） Strict inspection procedures and strict work discipline GSP tracking inspection shall refer to the certification procedures, adopt the way of flight inspection, and strictly follow the GSP site inspection guidelines (Revised Version) Inspectors should strictly abide by the discipline of certification and inspection, conscientiously perform their duties, enforce the law fairly and civilly, and consciously accept supervision The inspection records shall objectively evaluate the defects existing in the enterprise and truthfully reflect the inspection situation The Provincial Bureau will inform the discipline inspection and supervision department of discipline accountability in case of any dereliction of duty or dishonesty Hereby inform